Validation Engineering

Validation Engineer III
The Validation Engineer III will serve as a key member of the validation team, providing expert-level support to ensure facility equipment, utilities, processes, instrumentation, and computerized systems are qualified and maintained in a validated state in compliance with applicable regulatory requirements. The Validation Engineer III will coordinate and execute qualification activities while collaborating with internal stakeholders and external vendors to support ongoing operations and capital projects.
Establish, revise, and maintain validation master plans, procedures, and lifecycle documentation for qualification of equipment, systems, and processes in accordance with cGMP requirements
Execute and oversee IQ/OQ/PQ protocols for equipment, utilities, and systems
Review and complete documentation in accordance with cGMP, ALCOA+ principles, and data integrity requirements
Lead and manage validation-related project activities including scheduling, resource coordination, protocol execution, and report review
Manage external vendors and contractors performing qualification activities
Serve as a key member of project teams for design, procurement, installation, and commissioning of new equipment and facility expansion projects
Develop and maintain validation project timelines and deliverables
Identify validation requirements necessary to maintain systems in a validated state following change implementation
Manage periodic requalification activities to ensure equipment, utilities, and processes remain compliant
Support equipment and building monitoring systems compliance and updates
Serve as Subject Matter Expert (SME) in one or more of the following disciplines:
Quality Management (Quality Risk Assessments; Equipment qualification (autoclaves, controlled temperature units, filling equipment)
Computer system validation (CSV)
Process validation Utility qualification (WFI, purified water, clean steam, HVAC)
Environmental monitoring systems

Provide technical guidance and troubleshooting support for equipment and system failures
Deliver training on validation program elements to junior validation personnel
Author and support equipment and process-related deviation investigations and CAPA activities
Perform and support risk assessments (FMEA, etc.) and data integrity assessments
Support internal audits and regulatory agency inspections
Ensure all work is performed in accordance with SOPs, cGMPs, quality standards, and safety procedures
Bachelor's degree in Engineering, Life Sciences, or related scientific discipline required
Minimum 5+ years of professional experience in validation, engineering, or operations within a regulated environment
Minimum 4+ years of direct experience in a cGMP pharmaceutical, biotechnology, or medical device manufacturing environment
Experience with GMP utilities (WFI, purified water, clean steam, compressed gases, HVAC) and manufacturing equipment
Experience supporting regulatory inspections (FDA, EMA, or equivalent) preferred
Capital project experience including equipment design, selection, and commissioning preferred
Strong technical writing skills with ability to author clear, compliant documentation
Solid working knowledge of cGMP regulations, FDA guidance documents, and industry standards (ISPE, PDA, GAMP)
Understanding of GDP requirements and ALCOA+ data integrity principles
Strong project management and organizational skills
Ability to work independently with minimal supervision while also functioning effectively in a team environment
Proficiency in Microsoft Office Suite; experience with electronic validation systems a plus
On-site presence required; may involve work in manufacturing, laboratory, and utility areas
Occasional flexibility in schedule and travel may be needed to support project timelines or production schedules